Opana ER Painkiller Pulled from Market at FDA Request

Last month marked the first time ever that the U.S. Food and Drug Administration (FDA) requested a drug company pull a painkiller of the market due to high potential for abuse. Endo International PLC announced Thursday it would abide by that request and stop selling Opana ER.

FDA Concludes Opana ER Too Risky to Stay on Market

Opana ER’s removal from the market is the final chapter in a series of moves against the drug.

In a March hearing, FDA advisers voted 18 to 8 against keeping Opana ER on the market. The agency reviewed the hearing and requested Endo stop marketing the drug in June.

While the drugmaker contended that the extended-release opioid is safe and effective when used as intended, the FDA has concluded that the drug is too risky to remain on the market, citing a shift from people crushing and snorting the pill to get high to injecting it instead.

In fact, Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to the sharing of needles.

This outbreak happened after a 2012 formulation change which was meant to make the drug harder to abuse. Endo wished to market the new formulation as abuse deterrent; however, the FDA denied Endo’s marketing request.

Dangers of Opioid Painkiller Abuse

  • The U.S. Centers for Disease Control and Prevention records about 14,800 prescription painkiller deaths every year – this is more deaths than those attributed to car accidents or gunshot wounds
  • Perhaps more alarming is that the rate of painkiller abuse has increased by 300 percent between 1999 and 2010. The rate of abuse is especially high among women, increasing 400 percent during the same time span.
  • When used during pregnancy, opioid painkillers can lead to birth defects including:
    • Spina Bifida
    • Hypocephaly
    • Conoventicular septal defect
    • Hypoplastic left heart syndrome
    • Atrial septal defect
    • Tetralogy of fallot
  • Nearly 1 in every 33 babies is born with a birth defect according to the CDC.  Birth defects are the leading cause of death in infants, and account for more than 20 percent of all 5,600 infant deaths each year.



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